Status:
COMPLETED
Phase II Trial of EOquin in High-risk Superficial Bladder Cancer
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Conditions:
Bladder Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A non-randomized, open-label phase II study to explore the feasibility, time to recurrence, duration of response and safety of the adjuvant intravesical instillation of EOquin (apaziquone) in patients...
Detailed Description
Endpoints: Time to recurrence, duration of response and safety Number of Patients: 53 patients Study Design: Non-randomized, open-label study. Key Inclusion Criteria: High-risk patients according t...
Eligibility Criteria
Inclusion
- 1\. Patients with high risk superficial bladder cancer according to EAU criteria defined as:
- pT1 and/or Grade 2b-3, or multiple and highly recurrent
- histologically confirmed carcinoma in situ 2. All visible lesions must be completely removed by transurethral resection (TUR) at entry to the study 3. Normal bimanual examination under anesthesia (no palpable masses) 4. Absence of upper urinary tract tumor confirmed by intravenous pyelography (IVP) or CT scan or retrograde urogram within 6 months from the beginning of treatment 5. Patient with ZUBROD-ECOG-WHO performance status of 0-2 (see Appendix 2) 6. Over 18 years of age 7. Patients must be fully informed of the investigational nature of the study and signed written informed consent must be obtained prior to any study specific investigations.
Exclusion
- Patients having muscle-invasive disease (T2 or greater)
- Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months
- Patients with existing urinary tract infection or recurrent severe bacterial cystitis
- Patients with urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra
- Patients with history of other primary malignancy (other than squamous or basal cell skin cancers or cone biopsied Cis of the uterine cervix or prostate carcinoma treated curatively with normal PSA values at inclusion) in the last five years
- Patients with active, uncontrolled impairment of the renal, hepatobiliary, cardiovascular, gastrointestinal, urogenital, neurologic or hematopoietic systems which, in the opinion of the investigator, would predispose to the development of complications from the administration of intravesical therapy and or general anesthesia
- Patients who, in the opinion of the investigator, cannot tolerate intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders)
- Women who are pregnant or lactating. Individuals of reproductive potential may not participate unless agreeing to use an effective contraceptive method for themselves and/or their sexual partner
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00141531
Start Date
July 1 2005
End Date
December 1 2009
Last Update
June 14 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
St Radboud University Hospital
Nijmegen, Netherlands